Intrawound Tobramycin Plus Vancomycin to Prevent Surgical Site Infection in Tibial Fractures

Importance: Previous research has suggested that intrawound vancomycin powder reduces deep surgical site infections among patients with periarticular tibial fractures at high risk of infection. It is unknown whether the addition of tobramycin powder further decreases infection rates. Objective: To compare whether the combination of tobramycin plus vancomycin vs vancomycin alone delivered as intrawound powder at the time of definitive fixation reduces deep surgical site infections. Design, Setting, and Participants: Open-label, assessor-masked, randomized clinical trial conducted at 39 US trauma centers. Eligible patients were adults with an operatively treated periarticular tibial fracture (either tibial plateau or pilon) who met 1 of 3 criteria for elevated infection risk. Enrollment occurred between June 18, 2021, and December 12, 2024 (final follow-up, July 15, 2025). Interventions: Intrawound tobramycin (1.2 g) plus vancomycin (1.0 g) powder vs intrawound vancomycin (1.0 g) powder delivered at the time of definitive fixation. Main Outcomes and Measures: The primary outcome was a deep surgical site infection requiring surgical management within 182 days of definitive fracture fixation. Secondary outcomes included deep surgical site infections with pathogens that were gram-negative only, deep surgical site infections with at least 1 pathogen that was gram-positive, deep surgical site infections with polymicrobial cultures, deep surgical site infections with negative culture results, and cellulitis or skin infections treated only with antibiotics. Results: Among the 1660 participants randomized, 1528 (mean age, 47.0 [SD, 14.3] years; 603 female [39.5%]; 925 male [60.5%]) were included in the primary analysis. Deep surgical site infections occurred in 51 of 753 participants (182-day probability, 7.4%) in the tobramycin plus vancomycin group and 47 of 775 participants (182-day probability, 6.6%) in the vancomycin alone group (hazard ratio, 1.11; 95% bayesian credible interval, 0.75-1.66; posterior probability of superiority, 29.7%). The threshold required for superiority was not reached for any secondary outcome. Conclusions and Relevance: Among patients with operatively treated periarticular tibial fractures at high risk of infection, adding intrawound tobramycin powder to vancomycin powder at the time of definitive fixation did not reduce deep surgical site infections compared with vancomycin powder alone. Trial Registration: ClinicalTrials.gov Identifier: NCT02227446.

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Journal
JAMA
Published
2026-04-15
DOI
https://doi.org/10.1001/jama.2026.4023
Primary Topic
Orthopedic Infections and Treatments
Type
article
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article

Intrawound Tobramycin Plus Vancomycin to Prevent Surgical Site Infection in Tibial Fractures

Christopher H. Renninger, J. Brett Goodman, Patrick J. Kellam, Geoffrey S. Marecek et al.
JAMA
Orthopedic Infections and Treatments
article

Intrawound Tobramycin Plus Vancomycin to Prevent Surgical Site Infection in Tibial Fractures

Christopher H. Renninger, J. Brett Goodman, Patrick J. Kellam, Geoffrey S. Marecek, Luke A. Lopas, Madhav A. Karunakar, Walter W. Virkus, Arun Aneja, Jeff E. Schulman, Jessica C. Rivera, Carol A. Lin, George R. Hanson, Eben A. Carroll, Timothy S. Achor, Devon T. Brameier, Steve B. Behrens, Christine Churchill, Andrew Choo, Dillon C. O’Neill, Sterling Boutte, Brian Mullis, Peter C. Krause, Yasmin Degani, Joshua L. Gary, Marilyn Heng, Elias Weston-Farber, Greg E. Gaski, Suna Chung, Paul E. Matuszewski, Thirushan Wignakumar, Stephen H. Sims, Jacob S.W. Borgida, Heather A. Vallier, Todd O. McKinley, Albert V. George, Kevin D. Phelps, Craig E. Klinger, Joseph R. Hsu, Derek S. Stenquist, Nishant Suneja, Aleksey Dvorzhinskiy, William M. Ricci, Arjan Malekzadeh, Robert E. Bilodeau, Laurence B. Kempton, Yohan Jang, Carlo Eikani, Devin S. Mullin, Rachel B. Seymour, Jonathan G. Eastman, Kristoff Reid, Robert A. Hymes, Luke Harmer, Rudy Castillo, Stephen J. Warner, J. Cohen, Laura Blum, Lauren C. Hill, Martha B. Holden, Thomas J. Policicchio, Chelsey L. Recendez, Roman M. Natoli, David Teague, Richard E. Thompson, Jan P. Szatkowski, Ida Leah Gitajn, Carolyn Bridgman, Maithili S. Acharya, Gable B. Moffitt, Holly T. Pilson, Ashley Elizabeth Levack, Enosh Ishman, Michael J. Weaver, Luz M. Chavez-Araujo, Anthony R. Carlini, Maria Chavez, Todd Conlan, Hayden Callahan, Gregory M. Schrank, Lillian Adelaide Fisher, Olutayo M. Alese, Joshua S. Kendall, Catherine Young, Anna Vergon Tucci, Thuan V. Ly, Kara R. Haim, Abraham M. Goch, Michelle Kudulis, Michael P. Gambuzza, Nathan N. O’Hara, Susan C. Collins, Robert V. O’Toole, James Ahn, Nicholas D. Mullis, Keyla Denniss Guevara, Michael Holzman, Alan L. Jones, Charles Moon, Andrea L. Howe, William Obremskey
article en

Abstract

Importance: Previous research has suggested that intrawound vancomycin powder reduces deep surgical site infections among patients with periarticular tibial fractures at high risk of infection. It is unknown whether the addition of tobramycin powder further decreases infection rates. Objective: To compare whether the combination of tobramycin plus vancomycin vs vancomycin alone delivered as intrawound powder at the time of definitive fixation reduces deep surgical site infections. Design, Setting, and Participants: Open-label, assessor-masked, randomized clinical trial conducted at 39 US trauma centers. Eligible patients were adults with an operatively treated periarticular tibial fracture (either tibial plateau or pilon) who met 1 of 3 criteria for elevated infection risk. Enrollment occurred between June 18, 2021, and December 12, 2024 (final follow-up, July 15, 2025). Interventions: Intrawound tobramycin (1.2 g) plus vancomycin (1.0 g) powder vs intrawound vancomycin (1.0 g) powder delivered at the time of definitive fixation. Main Outcomes and Measures: The primary outcome was a deep surgical site infection requiring surgical management within 182 days of definitive fracture fixation. Secondary outcomes included deep surgical site infections with pathogens that were gram-negative only, deep surgical site infections with at least 1 pathogen that was gram-positive, deep surgical site infections with polymicrobial cultures, deep surgical site infections with negative culture results, and cellulitis or skin infections treated only with antibiotics. Results: Among the 1660 participants randomized, 1528 (mean age, 47.0 [SD, 14.3] years; 603 female [39.5%]; 925 male [60.5%]) were included in the primary analysis. Deep surgical site infections occurred in 51 of 753 participants (182-day probability, 7.4%) in the tobramycin plus vancomycin group and 47 of 775 participants (182-day probability, 6.6%) in the vancomycin alone group (hazard ratio, 1.11; 95% bayesian credible interval, 0.75-1.66; posterior probability of superiority, 29.7%). The threshold required for superiority was not reached for any secondary outcome. Conclusions and Relevance: Among patients with operatively treated periarticular tibial fractures at high risk of infection, adding intrawound tobramycin powder to vancomycin powder at the time of definitive fixation did not reduce deep surgical site infections compared with vancomycin powder alone. Trial Registration: ClinicalTrials.gov Identifier: NCT02227446.

JAMA
Brighton and Sussex Medical School (GB), University of Southern California (US), Louisiana State University (US), University of Maryland, Baltimore (US), Atrium Health Wake Forest Baptist (US), Cedars-Sinai Medical Center (US), Brigham and Women's Hospital (US), Dartmouth–Hitchcock Medical Center (US), MetroHealth (US), Loyola University Medical Center (US), Harvard University (US), University of Kentucky (US), Johns Hopkins University (US), Medical University of South Carolina (US), Loma Linda University (US), Walter Reed National Military Medical Center (US), Inova Fairfax Hospital (US), New York Hospital Queens (US), Harvard University Press (US), Carolinas Medical Center (US), University of Oklahoma Medical Center (US), Methodist Hospital (US), Presbyterian Hospital (US), Hennepin Healthcare Research Institute (US), MetroHealth Medical Center (US), Baylor Scott & White Health (US), Corewell Health, Indiana University – Purdue University Indianapolis (US), Vanderbilt University Medical Center (US), The University of Texas Health Science Center at Houston (US)
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Orthopedic Infections and Treatments
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